Pharmacovigilance Committee Sample Clauses

Pharmacovigilance Committee. Without limiting the generality of, and subject to, the foregoing, the Parties shall establish a pharmacovigilance committee (the “Pharmacovigilance Committee” or “PVC”) as a Sub-Committee at an appropriate time, but in any event prior to the earlier of (a) [***], or (b) [***]. In addition to any other matters that the JSC may delegate to the PVC, the PVC shall provide a forum for the Parties to discuss and share information regarding the safety of the Licensed Products and other pharmacovigilance matters worldwide in accordance with the Pharmacovigilance Agreement.
Sample 1
AutoNDA by SimpleDocs
Pharmacovigilance Committee. Without limiting the generality of, and subject to, Section 3.5.1 (Sub-Committees), the pharmacovigilance committee (the “Pharmacovigilance Committee” or “PVC”) will be a Sub-Committee of the JSC. As of the Effective Date, the PVC will be the pharmacovigilance committee established under the U.S. Collaboration and License Agreement. At any time during the Term the Parties may, and immediately upon the conclusion of the term of the U.S. Collaboration and License Agreement the Parties will, establish a PVC that is separate from the pharmacovigilance committee established under the U.S. Collaboration and License Agreement. If the Parties establish a PVC that is separate from the pharmacovigilance committee established under the U.S. Collaboration and License Agreement, then the Parties will establish such PVC at an appropriate time, but in any event prior to the earlier of (a) [***], or (b) [***]. In addition to any other matters that the JSC may delegate to the PVC, the PVC will provide a forum for the Parties to discuss and share information regarding the safety of the Licensed Products and other pharmacovigilance matters worldwide, including safety and pharmacovigilance matters arising under this Agreement in accordance with the Pharmacovigilance Agreement.
Sample 1

Related to Pharmacovigilance Committee

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Steering Committee Each Party shall name a mutually agreed upon equal number of representatives for the Steering Committee, which shall meet twice per calendar year, or as otherwise mutually agreed by the Parties. In the event that a Steering Committee dispute cannot be resolved, such dispute shall be escalated to a senior executive of each of Customer and Lonza. The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Joint Development Committee The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.

  • Research Committee 2.2.1 Establishment and Functions of the RC. -------------------------------------

  • Advisory Committee (a) The Partnership shall have a committee (the “Advisory Committee”) consisting of Fund Investors or their representatives or designees selected by the Managing General Partner; provided that no member of the Advisory Committee shall be an Affiliate of the Managing General Partner (or a designee or representative thereof). The Managing General Partner will meet with the Advisory Committee at least semi-annually to consult on various matters concerning the Partnership, including financial statements and appraisals, the status of existing investments and such other matters as the Managing General Partner may determine or any member of the Advisory Committee may reasonably propose.

  • Compliance Committee (1) Within thirty (30) days of the date of this Agreement, the Board shall appoint a Compliance Committee of at least five (5) directors, of which no more than one (1) shall be an employee or controlling shareholder of the Bank or any of its affiliates (as the term “affiliate” is defined in 12 U.S.C. § 371c(b)(1)), or a family member of any such person. Upon appointment, the names of the members of the Compliance Committee and, in the event of a change of the membership, the name of any new member shall be submitted in writing to the Assistant Deputy Comptroller. The Compliance Committee shall be responsible for monitoring and coordinating the Bank’s adherence to the provisions of this Agreement.

  • Operating Committee 7.01 To coordinate the operation of their respective generating, transmission and substation facilities, in order that the advantages to be derived hereunder may be realized by the parties hereto to the fullest practicable extent, the parties shall establish a committee of authorized representatives to be known as the Operating Committee. Each of the parties shall designate in writing delivered to the other party, the person who is to act as its representative on said committee (and the person or persons who may serve as alternates whenever such representative is unable to act). Each of such representatives and alternates shall be persons familiar with the generating, transmission, and substation facilities of the system of the party he represents, and each shall be fully authorized (1) to cooperate with the other representative (or alternates) and (2) to determine and agree from time to time, in accordance with this agreement and with any other relevant agreements then in effect between the parties, upon the following:

Time is Money Join Law Insider Premium to draft better contracts faster.